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Outlook Surgical Versa One System (8900139)

by Resnent, LLC

510(k) K241731

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK241731 Date11 Aug 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EOB
Device Class
Class II
Regulation
21 CFR Part 874.4760
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Outlook Surgical Versa One System (8900139) is a nasopharyngoscope (flexible or rigid) and accessories, classified as a Class II medical device under product code EOB and regulation number 874.4760. It is indicated for use in ear, nose, and throat (ENT) procedures as determined by the advisory committee review.

The device received FDA 510(k) clearance (K241731) on August 11, 2025, following a traditional review process. It is manufactured by Resnent, LLC and is supplied as a finished device for use in clinical ENT settings, with no claims made regarding sterility, single-use or reusable status, MRI safety, sizes, storage conditions, or additional authorizations beyond the FDA 510(k) clearance.